Immunosuppressant Regimens for Living Fetuses Study

Summary

Undifferentiated connective tissue diseases (UCTD) are known to increase the risk of pregnancy morbidities, including recurrent pregnancy loss. However, there is no consensus or guideline about the treatment for recurrent pregnancy loss in UCTD patients. Therefore, based on the tendency to thrombosis formation and placental inflammation in the pathogenesis of UCTD, this trial proposes to evaluate the effect of hydroxychloroquine with or without prednisone combined with anticoagulation on pregnancy outcomes in recurrent pregnancy loss patients with UCTD.

Conditions

• Undifferentiated Connective Tissue Disease
• Recurrent Pregnancy Loss

Interventions

DRUG

Prednisone

10mg once daily orally

DRUG

Hydroxychloroquine

100mg to 200mg twice daily orally

DRUG

Aspirin

50mg once daily orally

DRUG

low molecular weight heparin

Enoxaparin 40mg once daily subcutaneous or dalteparin 5000IU once daily subcutaneous or nadroparin calcium 4100U once daily subcutaneous

Sponsors & Collaborators

• The First Affiliated Hospital of Anhui Medical University

  collaborator OTHER

• China-Japan Union Hospital, Jilin University

  collaborator OTHER

• Wuxi No. 2 People's Hospital

  collaborator OTHER

• The First Affiliated Hospital with Nanjing Medical University

  collaborator OTHER

• Xiangya Hospital of Central South University

  collaborator OTHER

• RenJi Hospital

  lead OTHER

Principal Investigators

• Liangjing Lu · RenJi Hospital

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

20 Years

Max Age

40 Years

Sex

FEMALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2019-08-02

Primary Completion

2021-09-30

Completion

2023-02-28

Countries

• China

Study Locations